The FDA ordered an end to sales of all remaining surgical mesh products used for transvaginal fix of pelvic organ prolapse.
While the meeting was meant to facilitate discussion on factors like study design and physician training, the agency cited the panel's recommendation that mesh companies must demonstrate superior product effectiveness and comparable safety to native tissue fix at 36 months as grounds for Tuesday's move, saying the manufacturers failed to provide data meeting that standard.
In 2016, the FDA reclassified surgical mesh products intended for transvaginal fix to indicate they were the most high risk of devices the agency evaluated, according to an agency statement.
"For these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to fix POP".
The companies will now have 10 days to submit their plan to withdraw these products from the market, the agency said in a statement.
In Canada and the US, thousands of women reported that the plastic-covered mesh eroded inside them, causing intense pelvic pain and autoimmune symptoms.
Surgical mesh has been used since the 1950s to fix abdominal hernias. "Speaking as a woman, surgeon, scientist and healer, I know the decision by the FDA to pull vaginal mesh is a disservice to women". Several other major manufacturers, including Johnson & Johnson, previously stopped making the mesh.
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The affected mesh devices are Boston Scientific's Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System and Coloplast's Restorelle DirectFix Anterior.
"Too many women and men have been harmed by surgical mesh that was allowed on the market without any requirement for clinical trials", Zuckerman told Drugwatch. In 2016, the agency reclassified the mesh as high-risk.
Patient advocates and consumer watchdog groups applaud the FDA's crackdown on mesh. "The problems don't end with POP mesh being removed".
The agency said Tuesday that women with the pelvic mesh should continue regular checkups. Women with the mesh in place should continue with annual or routine check-ups and follow-up care, and no action is needed so long as they remain satisfied with the surgery and are not having complications, the FDA advised.
Both Boston Scientific and Coloplast, as well as other past manufacturers, have been the subjects of multimillion-dollar lawsuits and settlements over the devices-with the Denmark-based Coloplast reportedly paying $16 million to settle lawsuits in 2014, and Boston Scientific finding itself hit with a $100 million verdict.
"FDA's requiring clinical trials for mesh used for pelvic organ prolapse was an important first step, but the thousands of patients harmed by surgical mesh clearly show that clinical trials should be required for all types of surgical mesh", she said in an email.
Those who do have complications or symptoms - such as persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex - should see their health care provider, the agency added. It added that the proportion of women undergoing the mesh procedures decreased after the FDA began issuing warnings.